Covid-19: Johnson & Johnson Put in Charge of Plant That Ruined Millions of Vaccine Doses – The New York Times
April 5, 2021
Heres what you need to know:The biopharmaceutical company Emergent BioSolutions,a contract manufacturer of coronavirus vaccine.Credit...Jim Lo Scalzo/EPA, via Shutterstock
The Biden administration on Saturday put Johnson & Johnson in charge of a Baltimore contract plant that ruined 15 million doses of its Covid-19 vaccine, and moved to stop the facility from making another vaccine, developed by AstraZeneca, senior federal health officials said.
The extraordinary move by the Department of Health and Human Services will leave the Emergent BioSolutions facility solely devoted to making the Johnson & Johnson single-dose vaccine and is meant to avoid future mix-ups, according to two senior federal health officials. Johnson & Johnson confirmed the changes, saying it was assuming full responsibility for the vaccine made by Emergent.
The change came in response to the recent disclosure that Emergent, a manufacturing partner to both AstraZeneca and Johnson & Johnson, accidentally mixed up the ingredients from the two different vaccines, which forced regulators to delay authorization of the plants production lines.
Federal officials are worried that the mix-up will erode public confidence in the vaccines, just as President Biden is making an aggressive push to have enough vaccine doses to cover every American adult by the end of May. At the same time, there is deep concern about the safety of the AstraZeneca vaccine, amid a health scare that has prompted some European countries to restrict its use.
AstraZeneca said in a statement that it would work with the Biden administration to find an alternative site.
The ingredient mix-up, and Saturdays move by the administration, is a significant setback and public relations debacle for Emergent, a Maryland biotech company that has built a profitable business by teaming up with the federal government, primarily by selling its anthrax vaccines to the Strategic National Stockpile.
A spokesman for Emergent declined to comment, except to say that the company would continue making AstraZeneca doses until it received a contract modification from the federal government.
Experts in vaccine manufacturing said that in the past, the Food and Drug Administration had a rule to prevent such mishaps by not allowing a facility to make two live viral vector vaccines, because of the potential for mix-ups and contamination.
Unlike Johnson & Johnson, AstraZeneca does not yet have emergency F.D.A. authorization for its vaccine. With three federally authorized vaccines (the other two are by Pfizer-BioNTech and Moderna), it is unclear whether the AstraZeneca vaccine, which has had a troubled history with regulators, could even be cleared in time to meet U.S. needs.
However, one of the federal officials said the Health and Human Services Department was discussing working with AstraZeneca to adapt its vaccine to combat new coronavirus variants.
None of the Johnson & Johnson doses made by Emergent have been released by the F.D.A. for distribution. The agencys acting commissioner, Dr. Janet Woodcock, said in a statement that the agency takes its responsibility for helping to ensure the quality of manufacturing of vaccines and other medical products for use during this pandemic very seriously.
But she made clear that the ultimate responsibility rested with Johnson & Johnson. It is important to note that even when companies use contract manufacturing organizations, it is ultimately the responsibility of the company that holds the emergency use authorization to ensure that the quality standards of the F.D.A. are met.
Emergents Baltimore facility is one of two facilities that were built with taxpayer support and are federally designated as Centers for Innovation in Advanced Development and Manufacturing. Last June, the government paid Emergent $628 million to reserve space there as part of Operation Warp Speed, the Trump administrations fast-track initiative to develop coronavirus vaccines.
Johnson & Johnson and AstraZeneca both contracted with Emergent to use the space. Both companies vaccines are so-called live viral-vector vaccines, meaning they use a modified, harmless version of a different virus as a vector, or carrier, to deliver instructions to the bodys immune system. The Johnson & Johnson vaccine is one dose; AstraZenecas vaccine is two doses.
Last month, Mr. Biden canceled a visit to the Emergent Baltimore plant, and his spokeswoman announced that the administration would conduct an audit of the Strategic National Stockpile, the nations emergency medical reserve. Both actions came after a New York Times investigation into how the company gained outsize influence over the repository.
For the first time, more than three million people, on average, are receiving a Covid-19 vaccine each day in the United States, according to data from the Centers for Disease Control and Prevention. And on Saturday, the country reported over four million doses in a single day for the first time.
The milestones reflect a steady increase in the capacity of states to deliver shots into arms. In early March, the nation surpassed an average of two million doses administered each day, up from around 800,000 doses a day in mid-January. Nearly a third of the United States population has received at least one dose of a Covid-19 vaccine as more states expand eligibility and production ramps up.
The news, which comes as President Biden enters the homestretch of his first 100 days in office and amid the general declines in new virus cases, deaths and hospitalizations since January, offers a sign of hope for a weary nation. But the average number of new reported cases has risen 19 percent over the past two weeks, and federal health officials say that complacency about the coronavirus could bring on another severe wave of infections.
We have so much to look forward to, so much promise and potential of where we are, and so much reason for hope, Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said in an emotional plea to Americans this week. But right now Im scared.
The rising vaccination rate has prompted some state officials to accelerate their rollout schedules. This week, Gov. Ned Lamont of Connecticut expanded access to people 16 and older, several days ahead of schedule. And Gov. Jared Polis of Colorado opened universal eligibility about two weeks earlier than planned.
No more having to sort out if youre in or if youre out, said Julie Willems Van Dijk, the deputy secretary of the Department of Health Services in Wisconsin, where anyone 16 or older will be eligible for a vaccine as of Monday. Its time to just move forward and get everybody with a shot in their arm.
In another promising development, federal health officials said on Friday that Americans who are fully vaccinated against the coronavirus can travel at low risk to themselves within the United States and abroad.
But these days, most signs of hope are offset by peril.
Over the past week, there has been an average of 64,730 cases per day, an increase of 19 percent from two weeks earlier, according to a New York Times database. New deaths on average have declined, but they are still hovering around 900 a day. More than 960 were reported on Friday alone.
The C.D.C. predicted this week that the number of new Covid-19 cases per week in the United States would remain stable or have an uncertain trend over the next four weeks, and that weekly case numbers could be as high as about 700,000 even in late April.
Cases are already increasing significantly in many states, particularly in the Midwest and Northeast, as variants of the virus spread and some governors relax mask mandates and other restrictions. Dr. Walensky said this week that if states and cities continued to loosen public health restrictions, the nation could face a potential fourth wave.
Michigan, one of the worst-hit states, is reporting nearly 6,000 cases a day up from about 1,000 a day in late February even though half of its residents over 65 are now fully vaccinated.
And in Ohio, Gov. Mike DeWine said that new variants were aggravating the states caseload, even as vaccinations picked up.
We have to understand that we are in a battle, he said.
As if to underscore how fragile the nations recovery is, a quintessential American ritual the start of the baseball season has already faced a virus-related delay.
Major League Baseball officials said on Friday that the league had found only five positive cases in more than 14,000 tests of league personnel. But because four of those people were Washington Nationals players, the teams Opening Day game against the New York Mets was postponed, and then the teams full three-game weekend series.
Its one of those things that brings it to light that were not through it yet, Brian Snitker, the Atlanta Braves manager, told The Associated Press. Were still fighting this.
Benjamin Guggenheim,Lauryn Higgins and Mike Ives
In Ohio, Gov. Mike DeWine offered school districts early access to Covid-19 vaccines for their staff members if they committed to opening classrooms by March 1.
In Washington, Gov. Jay Inslee declared a state of emergency related to child and adolescent mental health and banned fully virtual instruction starting in April.
In Massachusetts, Gov. Charlie Baker announced that most elementary schools would be required to offer full-time in-person instruction by April 5, and most middle schools by April 28.
The three are part of a significant and bipartisan group of governors who have decided it is time to flex some muscle and get students back into classrooms, despite union resistance and bureaucratic hesitancy.
The push has come from both ends of the political spectrum. Democratic governors in Oregon, California, New Mexico and North Carolina, and Republicans in Arizona, Iowa, New Hampshire and West Virginia, among other states, have all taken steps to prod, and sometimes force, districts to open.
The result has been a major increase in the number of students who now have the option of attending school in person, or will in the next month.
According to a school reopening tracker created by the American Enterprise Institute, 7 percent of the more than 8,000 districts being tracked were operating fully remotely on March 22, the lowest percentage since the tracker was started in November. Forty-one percent of districts were offering full-time in-person instruction, the highest percentage in that time. Those findings have been echoed by other surveys.
In interviews, several governors described the factors motivating their decision to push districts to reopen, including the substantial evidence that there is little virus transmission in schools if mitigation measures are followed, the decline in overall cases from their January peak, and, most of all, the urgency of getting students back in classrooms before the school year ends.
Every day is an eternity for a young person, Mr. Inslee, a Democrat, said. We just could not wait any further.
In the weeks since most of the governors acted, nationwide cases have started to rise again, which could complicate the effort to get children back in school. Many school staff members have already been offered vaccines, which has reduced the resistance from teachers unions to reopening and, provided staff vaccination rates are high, will limit opportunities for the virus to spread in schools.
Even so, in areas where cases are increasing sharply, like Michigan, some schools have had to revert to remote learning temporarily because so many students were in quarantine.
But for the time being, at least, the moves by these governors have yielded significant results.
In Ohio, nearly half of all students were in districts that were fully remote at the beginning of 2021. By March 1, that number was down to 4 percent, and it has shrunk further in the weeks since.
In Washington, before Mr. Inslee issued his proclamation, the states largest district, Seattle Public Schools, was locked in a standoff with its teachers union over a reopening plan. Days after Mr. Inslee announced he would require districts to bring students back at least part time, the two sides reached an agreement for all preschool and elementary school students and some older students with disabilities to return by April 5.
And in Massachusetts, the move by Mr. Baker, a Republican, has spurred a sea change, with dozens of districts bringing students back to school for the first time since the pandemic began, and hundreds shifting from part-time to full-time schedules.
Its worked exceedingly well, Mr. DeWine, also a Republican, said of his decision to offer vaccines to Ohio districts that pledged to reopen. Weve got these kids back in school.
JERUSALEM In the Old City of Jerusalem on Friday morning, in the alleys of the Christian quarter, it was as if the pandemic had never happened.
The winding passageways that form the Via Dolorosa, along which Christians believe Jesus hauled his cross toward his crucifixion, were packed with over 1,000 worshipers. The Good Friday procession, where the faithful retrace the route Jesus is said to have taken, was back.
It is like a miracle, said the Rev. Amjad Sabbara, a Roman Catholic priest who helped lead the procession. Were not doing this online. Were seeing the people in front of us.
Pandemic restrictions forced the cancellation of last years ceremony and required priests to hold services without congregants present. Now, thanks to Israels world-leading vaccine rollout, religious life in Jerusalem is edging back to normal. And on Friday, that brought crowds back to the citys streets, and relief to even one of Christianitys most solemn commemorations: the Good Friday procession.
For much of the past year, the pandemic kept the Old City eerily empty. But with nearly 60 percent of Israeli residents fully vaccinated, the citys streets were once again thrumming, even if international tourists were still absent.
At the gathering point for the procession on Friday, there was scarcely space to stand. The crowd moved slowly off, singing mournful hymns as they proceeded along what Christians consider a re-enactment of Jesus last steps.
In the alley outside the chapel of St. Simon of Cyrene, the marchers trailed their fingers over an ocher limestone in the chapel wall. According to tradition, Jesus steadied himself against the stone after a stumble.
Finally, they reached the Church of the Holy Sepulcher, which believers think was the site of Christs crucifixion, burial and, ultimately, resurrection.
For some, the Good Friday procession carried even more resonance than usual its themes of suffering, redemption and renewal seeming particularly symbolic as the end of a deadly pandemic appeared finally in sight.
We have gained hope again, said George Halis, 24, who is studying to be a priest and who lives in the Old City. Last year was like a darkness that came over all of earth.
But for now, that togetherness continues to face limits. There are still restrictions on the number of worshipers at Easter services. Masks are still a legal requirement. And foreigners still need an exemption to enter Israel keeping out thousands of pilgrims, at the expense of local shopkeepers who depend on their business.
A beloved superfan of the University of Alabamas mens basketball team died from complications of Covid-19, his mother said Saturday.
Luke Ratliff rarely missed a game and was known by the Crimson Tide community as Fluffopotamus. He died Friday evening, his mother, Pamela Ratliff, said. A senior at the University of Alabama, Mr. Ratliff was set to graduate in August. He was 23.
He had a personality that was bigger than this world, never met a stranger, Ms. Ratliff said on Saturday.
Mr. Ratliff traveled to the mens N.C.A.A. basketball tournament in Indianapolis to cheer on the Crimson Tide until they lost to U.C.L.A. last weekend. He had recently gone through rapid coronavirus testing multiple times, Ms. Ratliff said, and the tests had come back negative.
He didnt have any of the typical symptoms until the cough set in this week, she said.
Mr. Ratliff was eventually treated for bronchitis and it was later discovered he had contracted Covid-19.
Fans were allowed to fill venues for the tournament up to 25 percent of their normal capacity. In response to Mr. Ratliffs death, the Marion County Public Health Department said in a statement that it would be investigating to determine if anyone in Indianapolis may have been exposed to Covid-19 by any Alabama resident who visited Indianapolis in recent days.
We continue to encourage residents and visitors to practice the simple and important habits that keep us all safe: wearing a mask, washing hands, and social distancing, the department said.
There has been an outpouring of tributes from the Crimson Tide community celebrating Mr. Ratliff.
We will forever remember our #1 fan, Alabama Mens Basketball said on Twitter. We love you.
Nate Oats, Alabamas coach, said Mr. Ratliffs death doesnt seem real.
Fluff has been our biggest supporter since day one, Oats said on Twitter. Put all he had into our program. Loved sharing this ride with him. Youll be missed dearly my man! Wish we had one more victory cigar and hug together. Roll Tide Forever.
Mr. Ratliff described his love for college basketball to The Tuscaloosa News earlier this year.
College basketball is different because its literally right in front of you: You can see it, you can touch it, you can go to it 16 home games a year. Its tangible, thats whats endeared me to it, Mr. Ratliff told the outlet, discussing his preference for the game over football.
On March 31, Mr. Ratliff chronicled the Alabama mens basketball season on Twitter, posting his own personal highlights from the season.
I will finish college having attended 44 of the tides past 45 conference and postseason games, including 42 in a row, Mr. Ratliff wrote. What a freaking ride its been.
Mr. Ratliff is survived by his parents and two brothers.
Three hundred and eighty-seven days after Broadway went dark, a faint light started to glimmer on Saturday.
There were just two performers the tap dancer Savion Glover and the actor Nathan Lane, both of them Tony Award winners on a bare Broadway stage. But together they conjured up decades of theater lore.
The 36-minute event, before a masked audience of 150 scattered across an auditorium with 1,700 seats, was the first such experiment since the coronavirus pandemic forced all 41 Broadway houses to close on March 12, 2020.
Glover performed an improvisational song-and-dance number in which he seemed to summon specters of productions past A Chorus Line, The Tap Dance Kid, Dreamgirls, 42nd Street. He also made a pointed reference to Black life in the U.S., interpolating the phrase knee-on-your-neck America into a song from West Side Story.
Lane, one of Broadways biggest stars, performed a comedic monologue by Paul Rudnick, in which he portrayed a die-hard theater fan who dreams (or was it real?) that a parade of Broadway stars, led by Hugh Jackman, Patti LuPone and Audra McDonald, arrive at his rent-controlled apartment and proceed to vie for his attention while dishily one-upping one other.
The St. James, a city historic landmark built in 1927, was chosen in part because its big and empty. The theater also has a modern HVAC system, and its air filters were upgraded during the pandemic in an effort to reduce the spread of airborne viruses.
The event, while free, was invitation only, and the invitations went mostly to workers for two theater industry social service organizations, the Actors Fund and Broadway Cares/Equity Fights AIDS.
Californians will soon be able to gather indoors, the states public health department announced, edging toward a return to live entertainment as vaccination rates rise and the state recovers from a winter surge in coronavirus cases.
Fridays announcement is one of the latest examples of states easing Covid-19 restrictions as they loosen vaccine eligibility and more shots land in arms. Under the guidelines, gatherings, private events or meetings such as receptions or conferences, and indoor seated live events and performances will be permitted in some counties based on their Covid-19 risk levels, starting April 15.
As of March 30, most of the states counties are under the states red tier or under substantial Covid-19 risk, according to state data. Under the red tier, venues with over 1,500 capacity are limited to 20 percent capacity and proof of testing or full vaccination is required, outdoor gatherings of 25 people are allowed and private indoor events are allowed for up to 100 guests with proof of testing or full vaccination.
Residents can read specific guidelines under each tier in the states Blueprint for a Safer Economy.
Dr. Mark Ghaly, secretary of the California Health and Human Services Agency, said in a statement that the lift in restrictions showed the progress the state had made against the virus.
Professional sports teams, such as the Los Angeles Lakers and the Sacramento Kings, applauded the changes.
Coronavirus cases in the state have decreased about 12 percent in the past week to an average of 2,654 cases per day, according to a New York Times database. Almost 20 percent of Californias population is fully vaccinated.
Despite the positive trajectory, state officials are still warning that safety measures must be at the forefront of peoples minds even if some restrictions have loosened.
By following public health guidelines such as wearing masks and getting vaccinated when eligible, we can resume additional activities as we take steps to reduce risk, Dr. Ghaly said.
BUENOS AIRES President Alberto Fernndez of Argentina tested positive for the coronavirus on Saturday and was experiencing mild symptoms despite having been vaccinated earlier this year, becoming the latest in a series of world leaders who have contracted the virus.
Mr. Fernndez said on Twitter that a light headache and a temperature of 99.1 degrees had prompted him to take a rapid antigen test. Its positive finding was confirmed later Saturday by a more rigorous P.C.R. test, said Dr. Federico Saavedra, the presidents physician.
Mr. Fernndezs symptoms were mild due in large part to the protective effect of the vaccine, Dr. Saavedra said.
The president, who first learned the preliminary result on Friday, his 62nd birthday, said he would remain in isolation. I am physically well, and although I would have liked to end my birthday without this news, Im also in good spirits, he wrote on Twitter.
Mr. Fernndez joins a list of world leaders who have contracted the virus, including Andrs Manuel Lpez Obrador of Mexico, Jair Bolsonaro of Brazil, Emmanuel Macron of France and Donald Trump of the United States.
But Mr. Fernndez appears to be the first of those leaders to test positive for the virus after having been fully vaccinated. He received the first dose of Russias Sputnik V vaccine on Jan. 21 and the second on Feb. 11.
Read more from the original source:
Covid-19: Johnson & Johnson Put in Charge of Plant That Ruined Millions of Vaccine Doses - The New York Times
